Promoting Palliative Care for People With Heart Failure

NCT ID: NCT06933875

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project will develop and test a novel clinical decision support tool (CDS) that encourages timely referral to palliative care for people hospitalized with heart failure. This intervention will incorporate an existing, validated 1-year mortality risk model into a CDS to deliver prognostic information and evidence-based decision support at the point of care. Thus, this research may lead to improved care-concordant and goal-directed care for people with heart failure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Healthcare providers will encounter the tool during the routine care of their hospitalized patients. Providers randomized to the intervention arm will receive training on the use of the tool and complete one post-trial survey. Providers randomized to the intervention arm will also have the opportunity to participate in 1 post-trial interview. Level 2 providers will participate in one interview.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Palliative Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Providers who care for people hospitalized with heart failure at the two study sites will be recruited. Providers will be selected via retrospective chart review by study investigators. Eligibility of patients will be assessed automatically by an existing Epic build and will not involve any human intervention. When a provider opens the order entry screen of the patient's medical record, this build will examine the record for all inclusion and exclusion criteria. Those who meet criteria will be automatically enrolled and placed into a randomization group based on the randomization status of their current provider at the time of enrollment. Target sample size is 70 providers, 700-1400 participants and 15 Level 2 providers (providers potentially impacted by the tool).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinical Decision Support (CDS) Tool

Providers will use the CDS tool to deliver prognostic information and evidence-based decision support at the point of care for timely referral to palliative care for participants hospitalized with heart failure.

Group Type EXPERIMENTAL

Clinical Decision Support Tool

Intervention Type BEHAVIORAL

Deliver prognostic information and evidence-based decision support at the point of care

Standard of Care

Providers will provide usual standard of care for participants hospitalized with heart failure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Level 2 providers

Level 2 providers are providers potentially impacted by the tool. Level 2 providers will participate in one interview.

Group Type EXPERIMENTAL

Clinical Decision Support Tool

Intervention Type BEHAVIORAL

Deliver prognostic information and evidence-based decision support at the point of care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinical Decision Support Tool

Deliver prognostic information and evidence-based decision support at the point of care

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Healthcare providers must meet the following criteria:

* Are an attending physician, fellow, or resident, advanced practice nurse, or physician associate
* Has ordering privileges
* Are members of one of the hospitals' admitting teams (e.g., hospitalist service, cardiology service)
* Anticipate employment at one of the two study sites for the 15-month trial period.

Or

* Palliative care team member
* Hospital administrator/quality and safety personnel

Patients of providers enrolled in the study must meet the following criteria for heart failure during hospitalization:

* N-terminal pro-B-type natriuretic peptide values of \>500 pg/ml
* Not pregnant at the time of admission.
* Received intravenous diuretics within 24 hours of admission.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shelli Feder, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale New Haven Hospital Saint Raphael

New Haven, Connecticut, United States

Site Status

Yale New Haven Hospital York Street

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shelli Feder, PhD

Role: CONTACT

937-239-2801

Nathan Wright, MA

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R34HL174885-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000038269

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Congestive Heart Failure Outreach Program
NCT00371085 COMPLETED PHASE4
Enhancing Heart Failure Self-Care
NCT00526773 COMPLETED NA